Efficacy of an organic pomegranate polyphenol complex (VIQUA®) in type 1 primary osteoporosis in post-menopausal women

Double-blind, placebo-controlled clinical study to analyze the efficacy of an organic pomegranate polyphenol complex supplementation on bone mineral density, bone turnover markers, inflammatory status, and antioxidant status in post-menopausal women

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13473651

Enrollment

Registered

2023-07-07

Start date

2022-09-02

Completion date

Unknown

Last updated

2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of osteoporosis in postmenopausal women Musculoskeletal Diseases

Interventions

Subjects were randomly assigned in a 1:1 ratio to receive either the trial product VIQUA® (250mg in capsules) or Placebo (Dextrin 250mg in capsules) once daily (daily dosage of 300mg) for 36 weeks. Pa

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Post-menopausal female subjects 2. Aged between 45 and 70 years old 3. Subjects with at least 12 months of amenorrhea 4. T-score of -2.5 or less in bone mineral density analysis

Exclusion criteria

Exclusion criteria: 1. History of cancer or thyroid dysfunction 2. Hormone replacement therapy (HRT) within the last 6 months 3. Known allergy to any of the ingredients in the test product 4. Consumed any nutritional supplements within 1 month from the start of the study 5. Any serious mental or physical illnesses that might interfere with the outcome of the study

Design outcomes

Primary

Measure	Time frame
Change in bone mineral density (BMD) from baseline to 36 weeks. BMD of the lumbar spine and proximal femur are assessed by dual-energy x-ray absorptiometry at baseline, 12 weeks, 24 weeks, and 36 weeks	—

Secondary

Measure	Time frame
The following secondary outcome measures are assessed at baseline, and 12, 24, and 36 weeks: 1. Serum levels of bone turnover markers, osteocalcin, bone-specific alkaline phosphatase (BAP), receptor activator of nuclear factor kappa-B ligand (RANKL), and C-terminal telopeptide measured using biochemical analysis of blood 2. Inflammatory status measured using hs-CRP analysis in blood 3. Antioxidant status measured using Total Antioxidant Status analysis in blood	—

Measure

Time frame

The following secondary outcome measures are assessed at baseline, and 12, 24, and 36 weeks: 1. Serum levels of bone turnover markers, osteocalcin, bone-specific alkaline phosphatase (BAP), receptor activator of nuclear factor kappa-B ligand (RANKL), and C-terminal telopeptide measured using biochemical analysis of blood 2. Inflammatory status measured using hs-CRP analysis in blood 3. Antioxidant status measured using Total Antioxidant Status analysis in blood

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Countries

Japan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026